Senior Process Development Engineer - Pleasanton, CA

Calyxo • Pleasanton, CA

4h • $145,000 - $160,000 • Onsite

About The Position

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.
Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.
Summary:
The Senior Process Development Engineer will play a key part in product development by creating and optimizing manufacturing processes for new instruments. The role partners with R&D, Quality, and other cross-functional groups to ensure that new designs are manufacturable and scalable. The engineer will also be responsible for transferring new designs/processes into production, both locally and at international contract manufacturers.

Requirements

• Education: BS in Engineering or a combination of relevant education and experience.
• Minimum of 8 years of experience supporting medical device manufacturing. Experience with catheter manufacturing processes desired.
• Work location: Pleasanton, CA
• Travel: 10%
• Full time employment
• Experience in leading highly technical projects in a cross functional environment.
• Experience working in a structured design process such as ISO9000 or FDA QSR and knowledge of regulatory approval process and requirements.
• Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001 and EN46001.
• Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

Responsibilities

• Initiate, own, and complete technical projects resulting in new/improved processes for Calyxo products.
• Effectively communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines.
• Work closely with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability.
• Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
• Provide sustaining production line support, including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
• Train and support production personnel during transition of new products/processes to production, both locally and at international contract manufacturer.
• Generate and modify high-quality manufacturing process documentation and ensure that processes and documentation follow established policies and procedures.
• Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
• Assist in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment.
• Generate and modify component/assembly/equipment drawings using SolidWorks.
• Write and execute process and equipment validations (IQ/OQ/PQ).
• Ensure product quality and support regulatory compliance.

Benefits

• A competitive base salary of $145,000 - $160,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees